BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1511911 · Received October 7, 2009

    Report

    Report Number
    1823260-2009-06659
    Event Type
    Malfunction
    Date Received
    October 7, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 7, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE USE BY DATE ON THE COMPACT TEST STRIP VIAL AS 05/2005. MFR'S BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 01/31/2005. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCSE MONITORING TEST STRIPS -LFR LFR ROCHE DIAGNOSTICS 20613241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK